PRIMA — Medical mask with two layers
Green medical mask with two layers. Masks are described as Class 1 medical devices, but in the same time, as ,,General purpose face mask suitable for medical, food processing as well as industrial use."
⚖️ Von Behörden angeordnete Maßnahmen
- ▸ (to: Retailer) Withdrawal of the product from market
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What is this? PRIMA is a medical mask sold in Romania. It has two layers and a CE mark. The maker says it is a surgical mask, but it has not been checked by a European safety group.
What's happening? The mask may not meet safety rules. It might not protect you well unless you use other safety steps.
Does this affect me? If you bought or used this mask in Romania, it could affect you.
What should I do? Stop using the mask. Ask your pharmacist or doctor for advice on safe masks.
🤖 Diese allgemeinverständliche Zusammenfassung wird automatisch aus der offiziellen Mitteilung der Behörde mithilfe von KI erstellt. Sie dient nur zur allgemeinen Information – nicht als medizinischer Rat. Treffen Sie gesundheitsbezogene Entscheidungen immer in Absprache mit einer Apothekerin oder einem Arzt und lesen Sie die verlinkte offizielle Quelle unten.
🔬 Medizinische / technische Details Für Fachkräfte
Risk level: Other types of alerts · Type: Health risk / other · Category: Protective equipment · Hazard: The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. · Origin: People's Republic of China
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